Eptinezumab-Jjmr)

Vyepti® (eptinezumab-jjmr)

When requesting Vyepti® (eptinezumab-jjmr), the individual requiring treatment must be diagnosed with the following FDA-approved indication and meet the specific coverage guidelines and applicable safety criteria for the covered indication.

FDA-approved Indication

• Prevention of migraine headaches in adults

Coverage Guidelines

Migraine Headache Prevention

An individual must meet all of the following criteria for approval: • Is 18 years of age or older; • Has greater than or equal to 4 migraine headache days per month (prior to initiating a migraine-preventative medication); • Has tried at least two standard prophylactic pharmacologic therapies, each from a different pharmacologic class (e.g., angiotensin receptor blocker, angiotensin converting enzyme inhibitor, anticonvulsant, β-blocker, calcium channel blocker, tricyclic antidepressant, other antidepressant) and meets one of the following: o The patient has had inadequate efficacy to both of those standard prophylactic pharmacologic therapies; OR o The patient has experienced adverse event(s) severe enough to warrant discontinuation of both of those standard prophylactic pharmacologic therapies; OR o The patient has had inadequate efficacy to one standard prophylactic pharmacologic therapy and has experienced adverse event(s) severe enough to warrant discontinuation to another standard prophylactic pharmacologic therapy; AND • The patient meets one of the following: o Has tried at least one triptan therapy; OR o Has a contraindication to triptan(s).

Approval duration (initial and renewal): One year

Dosing Recommendations

• Up to 300 mg administered by intravenous infusion once every 3 months

1. Vyepti™ injection for intravenous use [prescribing information]. Bothell, WA: Lundbeck Seattle BioPharmaceuticals, Inc.; February 2020. 2. Headache Classification Subcommittee of the International Headache Society. The International Classification of Headache Disorders: 3rd edition (beta version). Cephalalgia. 2013;33:629-808. 3. MacGregor EA. In the clinic. Migraine. Ann Intern Med. 2017;166(7):ITC49-ITC64. 4. Lipton RB, Silberstein SD. Episodic and chronic migraine headache: breaking down barriers to optimal treatment and prevention. Headache. 2015;52:103-122. 5. American Headache Society. The American Headache Society position statement on integrating new migraine treatments into clinical practice. Headache. 2019;59:1-18. 6. Silberstein SD, Holland S, Freitag F, et al. Evidence-based guideline update: Pharmacologic treatment for episodic migraine prevention in adults. Report of the Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Neurology. 2012;78(17):1337-1345. 7. Ashina M, Saper J, Cady R, et al. Eptinezumab in episodic migraine: a randomized, double-blind, placebo- controlled study (PROMISE-1). Cephalalgia. 2020 Feb 19. [Epub ahead of print]. 8. Data on file. Eptinezumab-jjmr Pre-Approval Dossier, version 1.7. Lundbeck, Inc.; Deerfield, IL; received on March 2, 2020. 9. Aimovig® injection for subcutaneous use [prescribing information]. Thousand Oaks, CA: Amgen; October 2019. 10. Ajovy® injection for subcutaneous use [prescribing information]. North Wales, PA: Teva Pharmaceuticals USA, Inc.; January 2020. 11. Emgality® injection for subcutaneous use [prescribing information]. Indianapolis, IN: Eli Lilly and Company; December 2019.

jjmr) - (eptinezumab

® Vyepti